Indian Supreme Court Denies Novartis Cancer Drug Patent 288
beltsbear writes "Following a reasonable view of drug patents, the Indian courts have decided that making small changes to an existing patented drug are not worthy of a new patent. This ruling makes way for low cost Indian cancer drugs that will save lives. From the Article: 'Novartis lost a six-year legal battle after the court ruled that small changes and improvements to the drug Glivec did not amount to innovation deserving of a patent. The ruling opens the way for generic companies in India to manufacture and sell cheap copies of the drug in the developing world and has implications for HIV and other modern drugs too.'"
Huh? (Score:2)
Well I imagine that if these small changes are not enough to get a new patent, then they are saying that this new variation of the old drug falls under the protection of the old drug.
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except the old patent is probably expired / expiring.
Re:Huh? (Score:5, Interesting)
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Well I imagine that if these small changes are not enough to get a new patent, then they are saying that this new variation of the old drug falls under the protection of the old drug.
And you actually hit the nail on the head. You're entirely correct. Think about it this way, if the Original patten were still valid and another company came up with the same "Changes" could the first company sue under that patent and win? Of course they could. So how can that very same company claim that those changes are innovation? If they are innovation then the generic company should be able to make small changes and reproduce it.
India is a screwed up country but this is one area they are getting right
Re:Huh? (Score:5, Informative)
The 'technicality' is that drugs were not eligible for patent under their law at the time.
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Which means, being the cynic that I am, that our pharma companies lobbyists are to blame, er...... thank. They didn't get what they wanted soon enough.
This news pleases me.
It's a good thing... (Score:5, Informative)
A 30 day supply of 400mg tabs of Gleevec (imatinib sulfate) runs a lil over 6 thousand dollars. That's right, 6k a month to keep patients with CML, HES and certain stomach cancers alive. It's gone up over 2 thousand a month in the last 3 years alone.
If you have insurance, good insurance, you might pay around 50 bucks of that a month. Without insurance, you get to use prednisone til it or the cancer kills you.
Way to go pharmaceutical companies... and do you really think they are working on a cure when they can rake in thousands of dollars a month from each and every cancer patient??? Yeah right... think again... If they understand the cancer well enough to halt it in it's tracks for 90 to 95% of the patients that are treatable by this drug, and another 90 to 95 of those that take it are alive and in full remission 5+ years later, they certainly know enough to track down a cure if they were so inclined to do so.
Greedy bastards...
Re:It's a good thing... (Score:5, Interesting)
Oh and the numbers I gave are based on the U.S. Dollar, inside the United States.
I've been in remission for over 3 years thanks to Gleevec, but it still sucks that they (Novartis) push for profiteering over saving lives.
Re:It's a good thing... (Score:5, Insightful)
I'm happy to hear you're in remission, even though I don't know you personally.
You know, we have no problems taking peoples property under eminent domain for the "good of the people". There was a business owner where I used to live who was forced to sell his property to the local gov't because they needed to turn it into a parking lot to support the major retail center across the street. The reason put forth: the additional tax revenue would benefit the public. Of course the builder of this retail/hotel/restaurant center stood to profit the most and I am confident was the one who persuaded the city to take the property with the thought of increased revenue. Bastard.
I'd like to see eminent domain apply to drugs that would help save, or greatly prolong the lives of many people. That makes sense to me. But it's not the big companies who get screwed.....
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Re:It's a good thing... (Score:5, Insightful)
do you really think they are working on a cure when they can rake in thousands of dollars a month from each and every cancer patient??? Yeah right... think again...
I would expect all of the other drug companies to also want a piece of that pie. That means they have to come up with something that works better.
If they understand the cancer well enough to halt it in it's tracks for 90 to 95% of the patients that are treatable by this drug, and another 90 to 95 of those that take it are alive and in full remission 5+ years later, they certainly know enough to track down a cure if they were so inclined to do so.
Greedy bastards...
You are vastly, massively underestimating the complexity of cancer and of the human biology.
Re:It's a good thing... (Score:4, Interesting)
You appear to know about biology and related public policy, so let me ask a few questions:
1) Suppose I don't have insurance and get cancer. Why can't I simply opt out of the FAA regulation system? Why can't I get a less tested and less expensive medicine (with informed consent) the same way I would get a less expensive car? Is "death of the patient" really the best outcome?
2) The Hippocratic oath has a statement, words to the effect "first do no harm" [wikipedia.org]. Sometimes this is interpreted as "do more good than harm" (example: medicines which cause side effects) and sometimes as "do no harm whatsoever" (patient dies because treatment is not yet vetted, safe treatment but off-label application, &c). Shouldn't these two points of view be reconciled?
3) A car mechanic will give me a diagnosis of what's wrong with my car, and an accurate estimate of what it will take to fix it. He's then bound to that estimate by strong state laws which protect the consumer. If a doctor doesn't get the diagnosis right the first time, I have to pay for a 2nd diagnosis and cure and then possibly a third one until he gets it right. For surgery, you never know ahead of time how much it will cost, or even how many separate bills you will get. Should states have consumer protections laws for medicine, in the manner of automobile repair protections?
4) If not, why?
5) Doctors make educated guesses based on statistical inference. (Example: A Recent Maryland death from rabies [cbsnews.com]. The correct diagnosis was only determined after the patiend had died) An inexpensive broad-spectrum testing grid that identified [for example] 2,000 infectious agents would seem to be the answer, yet FDA testing requirements would make such a product prohibitively expensive. Why shouldn't we have a less-well-tested version which is cheap, and can be used for initial screening?
6) Magnifying glasses are available at the convenience mart. Why can't they sell inexpensive (but with limited functionality) hearing aids? Why are medical devices which do not directly affect the health of the patient (such as hearing aids) so expensive, and why do they require expensive fitting by professionals? Why can't artists build and sell prosthetic hand attachments?
Re:It's a good thing... (Score:4, Informative)
1. Because we have decided that the risk of people being swindled by quacks become too large if we allow that. What you can do is enlist in a test of a new drug, which should give you access to less tested drugs.
2. There really aren't two different points of view. In all applications of medicine, the chance of benefit must be weighed against the risk of harm. For tested medicine, we have a good estimate of them both, and a judgment can be made. For untested medicine, the prior plausibility of the harm/benefit ratio is deemed too unfavorable.
3-4. I don't know, as I don't know the American system. But remember that fixed prices moves the risk to the hospital or doctor, and they have to be compensated for taking that risk, so it will mean more expensive treatment.
5. The depends on the rate of false negatives and false positives. Any screening causes someone to experience side effects from unnecessary side effects, and some people to not get the treatment they need.
6. I imagine hearing aids are expensive because they are fiendishly advanced. Out ears are able to pick out sounds with abysmal S/N (next time you are in a crowded, noisy room, try to see how many different conversations you can listen to simply by choosing one over the other), and the hearing aids have to work with that system. Also, sweat and ear wax are not the least corrosive environment, and any leaching might be problematic. For prosthetics, I imagine it could be done, though the list of materials and the way the prosthetic sticks to the body might be a problem.
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They have a monopoly, courtesy of patents, on their respective fields.
Nope. The NIH funds a huge amount on research at it's main campus, and at research universities around the country. To the tune of about $30 Billion/year. People motivated to find cures (become famous, tenure at a major university in their field, pretty much guaranteed funding, tour the world giving lectures at universites as a guest speaker, plus a piece of the patent along with the university).
The drug companies do spend a lot on re
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A single injection of Neulasta is $6,000, and you get two a month for many standard chemotherapy treatments.
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There is no shortage of cancer patients. Pharmaceutical companies don't make their money on drugs that don't work. They make their money by making effective drugs that cure people. Do you seriously think there is some big conspiracy to keep cancer patients sick? Are you a fucking moron?
Drug companies have no shortage of sick people. People take up smoking every day. They also have to pay millions in legal fees not to mention insurance and paying for the research they have to do. The more risky the drug
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Re:It's a good thing... (Score:4, Insightful)
Errr, for profit is the normal reason. Why do you believe that it must be impossible to make a profit if other people can make a profit? You just have to do a good job if you want to do well. The idea of intellectual property is that you no longer have to bother doing a good job, you just have to own the right to something imaginary and you can make people pay for it. It is the most stupid and destructive idea ever. It will ruin people's lives for a long time and people will have to fight to get free of this idea. What is left of the US economy seems to be being based on this dream but it will get rejected just like it did in the middle ages. For hundreds of years, our economy and the economies of most of the world flourished without this BS, yet fools still think that it would be impossible to live without it.
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The idea of intellectual property is that you no longer have to bother doing a good job, you just have to own the right to something imaginary and you can make people pay for it.
The drugs are not "imaginary". And anyway, under capitalism, how can you stop the drug companies making profits off them?
I personally don't see why anyone should be allowed to make any profit at all from things like life-saving drugs. Their research and development should be publicly funded and the results freely available.
But that would be socialism, so I don't suppose many of the US readers here would be too keen on the idea. Obviously the free market will work out best, just as long as we get rid of
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Re:It's a good thing... (Score:4, Interesting)
Those millions often end up in the hands of the companies doing the research - or in the hands of the universities doing the research which is then given to those companies. Either way its just another way of providing more money to powerful corporations - our money.
More power to India if it can break the medical patent system and provide much needed drugs or treatments to those in need, and not just those who are rich and in need. We have been fed the line that the exclusive patents are needed or no research would be done on any new drugs.
Do you honestly think that is true? That researchers won't do any research suddenly? that all that money collected to help pay for research won't actually be collected any more?
All that will happen is that Big Pharma will make less billions than it does now, and more people will live longer and happier than they do now.
Re:It's a good thing... (Score:5, Interesting)
Do you honestly think that is true? That researchers won't do any research suddenly? that all that money collected to help pay for research won't actually be collected any more?
Certainly the researchers paid by Pharma companies (to the tune of tens of billions a year in the US) won't be doing research any longer. Those who work for the NIH would be completely unaffected by a change to the patent system.
There is a lot of ignorance about how the costs break down for drug development. Here is how it works:
1. Government and academic R&D spends a few million to come up with a cure for cancer in mice. Discovery makes front page of NYT.
2. Pharma company pays government or academic lab $100k to license the molecule. Activists point out that this amounts to corporate welfare.
3. Pharma company goes on to spend $10M to show that the molecule will never work in people. Drug dies with no publicity.
That's basically the drug development model - the drugs that actually get marketed are an aberration. Most companies do heavy investment in testing dozens of drug candidates per year (the ones that make it fairly far), and they only release maybe a few per decade. Far more drugs get rejected early in testing before anybody even hears about them.
However, once in a while you get to step 4:
4. Pharma company spends about $100M on the molecule and it works out. Activists point out that the company is making billions per year on a drug that only cost $100M.
You can only spend $100M to get a successful drug if you know in advance which drug will be successful. That only applies if you're copying the work done by some other company (though you don't need all that testing in the first place on a true copy). The reality is that it costs billions to come up with a new drug, because you have to test a lot of stuff that doesn't work.
Drug discovery is a bit like ice hockey, but make the goals about half their current size. Lots of passing and skating, little scoring.
Re:It's a good thing... (Score:4, Informative)
3. Pharma company goes on to spend $10M to show that the molecule will never work in people.
4. Pharma company spends about $100M on the molecule and it works out.
But in your hypothetical scenario you forgot the $2 billion [huffingtonpost.com] they spent on advertising and marketing.
I'm not faulting you, but every time criticism of pharmaceuticals comes up everybody raves about high research costs while ignoring that these are not the main expenditure. Apologists also tend to forget about sheer mountain of money "Big Pharma" rakes in each year. There's a line somewhere between "making a profit" and "being a malevolent drain on society", and I think they've crossed well over it.
And this doesn't mention all the potential "negative future revenue" drugs that might have been squashed or hidden away, but that's another topic.
Re:It's a good thing... (Score:4, Insightful)
Re:It's a good thing... (Score:4, Insightful)
The pharma industry does also research on its own but that is about turning the basic concepts discovered in proper research into products. The industry has been calling foul over patent limitations for ages. But they do not have a leg to stand on.
A lot of the so called innovation is turning something from subcutaneous shots into pills. I'm sorry, but that is nothing that takes BEEEELLLIONS to research. It's worthwhile. But it's not the tedious research bit where you painstakingly find out how an illness works and how to counter it. The basic groundwork that sometimes takes decades has already been done.
Pharma innovation is mostly about rounded corners. Whenever you hear the word "innovation" issues by an industry spokes critter ALWAYS think "rounded corners". Those are the guys who put receptionists into lab coats in their commercials.
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Huh? (Score:5, Insightful)
Depends on the "small change" (Score:3)
Patents on new drugs make sense. When these patents expire, the companies try to find some way to re-patent the drug. Too often, the change is from "take 2 25mg tablets twice a day" to "take 1 50mg tablet twice a day". In other words, the changes often really have nothing whatsoever to do with the actual active ingredient being delivered. Instead of capsules, the drug become a tablet; instead of a syrup it's now a capsule.
This case seems to be even more egregious, because Novartis did not even develop the o
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And if the "small change" actually makes a real difference in effectiveness, isn't that an argument that it _should_ be patentable?
The problem with that idea is that drug studies can't show a small difference in effectiveness.
Here's how the drug companies maintain their grip: They work on derivatives of the original drug which are slightly different but which do more or less the same thing, and have them ready before the patent on the existing drug expires. In the USA (and possibly other developed nations, but I haven't done the research) the approval of derivatives is fast-tracked. It is notably cheaper and the bar is much lower when
Legal Gray Market sale of cheaper generics in USA? (Score:2)
Someone could start a business importing the generics from India and selling them here in the USA legally, rather than those generics being a "gray market" product: http://en.wikipedia.org/wiki/G [wikipedia.org]
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That's the correct spelling for grey to you, colonist.
Actually, Wikipedia doesn't have a USA version, it has an English version.
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.
Damn you for being right about the "English" language, though. And you forgot to rub it in by using the word color with the Brit-spelling "colour". (jk. IAAA = i am an anglophile)
Re:Legal Gray Market sale of cheaper generics in U (Score:4, Insightful)
You're trying to talk sense to someone who thinks "American" is a language.
The word I'd normally use to describe such an exercise is, "futile".
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From the article that you linked to "A grey market or gray market, also known as parallel market,..." - It seems that the English version of the page that you cite is quite clear that there are 2 ways of spelling the word. I am British and when I write on that site I write in English and point out alternative spelling just as this writer has. There is nothing wrong with the page that you link to.
Birds do it, spelling bees do it, let's fall in... (Score:2)
Good news - now Novartis will make generics :-) (Score:5, Interesting)
Generic drugs made by third parties are sorely needed by non G8 nations across the world. Indian companies are the leaders in making generics....like Chinese companies in making electronics / hardware. The argument of multinationals pharma companies like NOVARTIS claims the high cost of R & D for inventing new drugs for keeping up the high price. This has been debunked by the report on TIME [time.com] (and many other sources) which proved the same drug or treatments costs vary highly depending on who pays. And such costs are amortized from G8 nations itself. Also none of these companies are making any losses in their balance sheet whatsoever...what they demand is permanent 'rent seeking'. [wikipedia.org]
Today's TIME has an OPED by their Delhi correspondent [time.com] with grave warnings on future of Indian pharma - the type of warnings issued by World Bank / IMF / West on Developing countries - basically on the lines on "do as I say, not as I do". I guess NOVARTIS marketing droids called TIME headquarters and asked them to run a sympathetic piece. We are talking about a company with $54 billion sales and $9 billion plus profit in 2012! Imagine their power. And now imagine the 'purported losses' on a few drugs going out of patent in developing countries - it will be negligible at best.
There is no way any Indian - except for the 2-3% of the elite - can afford a $2600 ~ Rs 130000 / - cost for a month long treatment. This is a country with no health social safety net other than public medical colleges and affordable primary health care facilities and medicines. (Private Health Insurance is a new phenomenon, slowly catching on, the advantages and disadvantages we know...we have to look at USA.)
The only argument which can be made against Indian generics - "if you can't afford the drug, why don't you suffer the consequences". I guess even the most hard nosed penny pinching corporate drone is not THAT heartless.
Instead of fighting the generic manufacturers, NOVARTIS should create their own special generic versions and beat them on a price point. But the suits running the show looked at some powerpoint and decided, lets first fight, if we lose start making generics.
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Instead of fighting the generic manufacturers, NOVARTIS should create their own special generic versions and beat them on a price point.
In the developing world, premium priced branded generics are turning into big money for pharmaceutical companies.
The people are very aware of counterfeit drugs, so they'll pay a premium for Bayer Aspirin
(festooned with holograms and safety seals on the boxes and bottle)
even though aspirin has been generic for an exceedingly long time.
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India has the 7th largest defense budget in the world at about $50 billion (US). They have a space program. They develop and maintain nuclear weapons.
All the talk about how poor India is and how they need free medicine is bullshit. They could pay for it but instead they choose the route of compulsory licenses and invalidating patents. Instead of working with drug companies to give them a fair profit while providing drugs, they want domestic companies to produce the generics and keep the profits (it's no cha
This is very big... (Score:5, Interesting)
"Evergreening"
This is a process where pharma companies make teeny weeny changes to compound and get a new patent, bypassing the 20 year limit on patents. Indian law(thankfully) does not allow "Evergreening". Patents cannot be issued on "new versions" or "slight changes".
The courts are very sensitive to this, and will not allow pharma companies to get away.
What this ruling has done is that many more common drugs can now be sold as generics. Cancer is a relatively rare disorder, but there are other more common diseases where patented drugs are very expensive.
With this ruling generics will get a big boost. Not only that, there is a push by the govt to prevent doctors from recommending "brands" and recommend generic brand name drugs which are 1/10 the cost, or even cheaper.
There has been lot of pressure by the WTO to allow corporate to plunder the masses, but the govt has held out on its own. There are many things wrong with India. Thankfully. patent system as it stands today is not one of the things wrong!
Unfortunately... (Score:2)
In developing countries like India, a lot of people die much earlier due to lack of healthcare. Diseases like malaria, dengue, JE etc., are very common. Parasitic infections are also high on body count. Many for the want of cheap medicine which the developed world can take for granted.
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Re:Innovation (Score:5, Interesting)
Only a complete fool, April or otherwise, would base anything on imaginary property. There is nothing intellectual about that.
Re:Innovation (Score:5, Insightful)
The only good patent is an expired patent.
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I hear you can make a really nice curry with expired patents.
Re:Innovation (Score:4, Interesting)
Re:Innovation (Score:5, Insightful)
ibid [slashdot.org].. That argument has been debunked a long time ago. Those millions aren't going where you think they are.
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Some of the money we spend on drugs today are used to test new drugs. If we are going to end the system we have today, I would prefer if we had a new system in place before that. So, what is your system for testing new drugs, and when can it be implemented? And remember, it really does cost hundreds of millions of dollars to be reasonably sure that a drug works a
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And remember, it really does cost hundreds of millions of dollars to be reasonably sure that a drug works and is safe, so your system had better be somewhat resistant towards corruption.
It is the current system that has issues with corruption, because the companies financing the testing have profit motives.
There is no magic to publicly funding non-profit research/testing. It would however seem like magic because it is safer and cheaper.
Re:Innovation (Score:5, Insightful)
...it really does cost hundreds of millions of dollars...
Yes, because it's closed market. The regulations are designed to make it too expensive to compete. It is the epitome of 'crony capitalism'. And the whole process is done behind closed doors. That must end. However none of this is going to happen until we stop reelecting company politicians who appoint company bureaucrats. And furthermore, the efficacy and safety of many of today's pharmaceuticals are highly dubious. We can do much better if we demand some transparency at the very least. Make them open the books. There should be nothing to prevent the government from hiring scientists to create drugs also. Let's give these companies some real competition. Put our tax dollars to work for us for a change, instead of subsidizing the industry.
Re:Innovation (Score:4, Insightful)
That being said, more transparency would be nice. At least force them to publish all human testing of the drugs. Or even better, remove the testing from the drug companies, though it would be problematic to ensure that they have no power over it.
As for the using government money for testing drugs, it is an intriguing idea, but corruption would still be a problem, given the amount of money at stake. I am not sure whether it would be a larger or smaller problem than today.
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In my opinion drug development is one of the few things that should never be delegated to private companies.
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Re:Innovation (Score:5, Informative)
Correction: the price of testing drugs is mostly due to the bribes that need to be applied for them to be approved and the patents granted.
About the closest thing to a bribe you'll see in first-world drug development is the payments to the doctors who participate in the clinical trials. That is actually a considerable part of the trial costs. The payment can't induce them to manipulate the trial results, since the doctors don't have the ability to do this (the trials are double-blind - if they lied and said the patient was doing better than they actually were it would just affect the placebo group as much). However, if you don't throw money at doctors they won't bother to tell their patients about the option of participating in the trial.
Unfortunately, sometimes the money does cause doctors to enroll patients for whom the trials are inappropriate. Companies actually try to stop this, because it is likely to result in a drug NOT being approved (if you give a pill to somebody who is not expected to benefit from it, you add noise to the data which is already quite noisy).
So, while lots of money in the pharma industry gets spent on lots of stuff, the fact remains that it does cost hundreds of millions of dollars to test drug candidates, and most of the time the testing demonstrates that the drug is not safe/effective.
Oh, I'm all for having the NIH competitively do drug development/testing/etc (and making the resulting drugs freely licensable within the US, for use in 3rd world countries, and in 1st world countries that make similar investments and reciprocate). However, I don't think that it will magically make the testing less expensive, unless the whole healthcare system changes so that doctors can be compelled to participate in trials without much additional compensation (that is something that would be more likely to work in a country with nationalized healthcare, though it is worth pointing out that clinical trials tend to happen on a global scale anyway).
In the drug industry the patent system is in part used to let the high-risk/high-cost of development pay for itself. A tweaked molecule might not be very innovative, but it is just as expensive to test. If rulings like this prevail then you simply won't see tweaked molecules developed using private money, even if the resulting drug is a substantial improvement for patients. Again, there are other ways to fund drug development, but I'd like to see those methods employed and demonstrated as successful before we just pull the plug on the drug industry. There is no reason that publicly funded efforts can't just compete with the private ones - the public drugs would be much cheaper for consumers so they'll have no trouble if the R&D labs manage to come up with the goods. The pharma industry has been laying off so many scientists of late that the NIH shouldn't have trouble hiring some...
Re:Innovation (Score:4, Insightful)
Capitalism is only good for iPhones or other unnecessary luxuries, since I don't give a toss if Apple can persuade people to spend five hundred quid on a piece of electronic jewellery
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But if you nationalize so many industries they might not be as profitable and then they couldn't pay as many people high salaries and those people would not have enough disposable income to buy iPhones and data contracts. Please before you make any drastic changes, think of the poor iPhones - they need owners to care for them. Think of the baby iPhones who will never taste the sweet sweet data from the cloud.
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You know what's even more simple and obvious -- make everything free, including unnecessary luxuries, and just rely on everyone's good nature to make the system work.
It's so simple and obvious I can't believe nobody has tried that before.
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To hell with safety.
Allow life-saving drugs to be developed more quickly and cheaply, give them an "experimental" classification complete with a legal waiver. If I'm going to die of cancer in 2-3 years without medicine, do you think I give a shit about "safety"? There's no shortage of volunteers for these kinds of drug trials.
Now that developing drugs just got cheaper, more pharma startups can enter the market, and the number of years drug patents last for can be reduced.
Since doing this would benefit every
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Re:Innovation (Score:5, Insightful)
Sure, but not the abuses of patents that we see now. If they want a new patent then develop a new drug. Don't just tweak the old one and demand a new monopoly on it.
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Until we have a better system in place for coming up with the hundreds of millions of dollars it takes to prove the efficacy and safety of a new drug
That's a recipe for stasis. If the requirement is a "better system" already implemented before we change the current system, then that day will never come. I'm not saying the current system should be totally junked tomorrow, but your requirements are impossibly high.
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Here is a perfect system.
Drug companies would be treated like food and vitamin company. They would need to list the ingredients and amounts in the drug. If what they sold didn't match the label they would be liable for any damages. That's it. Just like peanut butter can be a great cheap source of nutrition for some and a deadly poison for others. As long as the company lets you know there are peanuts in there it's up to you to eat it.
So no regulations required to prove a drug is safe or effective.
Get rid of
Re:Innovation (Score:5, Insightful)
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The FDA has a budget of around $4B with $2B from fees paid by drug manufacturers.
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Re:Innovation (Score:4, Insightful)
Only a complete fool, April or otherwise, would base anything on imaginary property. There is nothing intellectual about that.
All property is imaginary. Anything external to you can only be described as belonging to you because of the cultural and legal framework that defines property. Property is a matter of convention, not fact.
So intellectual property is no more or less foolish than any other kind of property.
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So intellectual property is no more or less foolish than any other kind of property.
The thing that is owned in "intellectual property" is not well defined. That's a pretty big difference to real property. The concept of intellectual property is not even wrong [wikipedia.org]. Calling each other foolish won't change that.
Re:Innovation (Score:5, Insightful)
It's a smart move, and I'm surprised that there aren't more governments catching on. If I can get cheap treatment in your country, it may even be cheaper to be treated there, including the plane ticket.
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Re:Innovation (Score:5, Insightful)
Is this akin to the "if we don't get unlimited copyright, the music will die"?
I highly doubt that this is going to make pharmacological research unprofitable. Maybe it will even lead to new medication when they can't milk the very same crap forever.
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Is this akin to the "if we don't get unlimited copyright, the music will die"?
If the price of making a track was hundreds of millions dollars and took five to ten years, yes. I guess it is akin to "without copyright, we would get no more blockbuster movies", with the difference that blockbuster movies does not keep people alive. Oh, and patents are for twenty years, not forever minus epsilon.
Re:Innovation (Score:5, Insightful)
My understanding is that the bulk of the money is spent on marketing and sales.
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Lilly estimated it cost them a billion to bring a new drug to market, and that was years ago. I think they were talking about drugs for major diseases. First, they have to find a promising compound, that isn't easy. Most compounds they try are worthless. They get some help from biologicals, but it only the first step. They must figure out how to synthesize it because there are not enough green plants to do the job. There are trials, and your drug can get dinged from any of these. The FDA in the U.S. require
Re:Innovation (Score:4, Insightful)
It depends on how you count failures.
If you ask me "how much does it cost to find out if this molecule is a good drug?" the answer would probably be around $1M - $100M. Most of the time relatively-inexpensive screening would figure out that it won't work. Other times it would require trials that would be aborted at various points in time, costing up to $100M.
If you ask me "how much was spent just on testing that one drug that was approved last week?" the answer would probably be around $100M. Successful drugs consume the upper limit of the testing costs since they need to go through the full gamut of testing to be approved.
If you ask me "what is the total R&D budget of a typical pharma company over 5 years divided by the number of approved drugs they've had in that period of time?" the answer would be in the billions. The reason for this is that most drugs turn out not to work, so before you can spend the $100M on the drug that works you first have to spend $100M on lots of molecules that don't work.
It really isn't hard to see for yourself. Most drug companies publicize their annual R&D investments (which don't go to stuff like marketing). They certainly publicize drug approvals. Just pick a company and do the math, but makes sure you count actual new drugs, and not just new indications (which are somewhat cheaper to come up with, and certainly lower risk).
Companies do spend more on marketing than research, but the research costs are still astronomical. There are other models, and I'm all for trying some out, but it would make sense to get a new drug discovery model working before simply dismantling the one we already have.
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Oh, and patents are for twenty years, not forever minus epsilon.
And that is in fact a key factor in the ruling: the patent _does_ end in 20 years, rather than 20 + 20 because we used a levorotatory protein + 20 because we added this binding agent that releases more smoothly over time + 20 because we adjusted the gel coating to resist acid better and deliver more of the drug to the intestines + 20 because...
Re:Innovation (Score:5, Insightful)
Financially it makes much more sense to take your existing product, make it slightly stronger or last slightly longer and file for a new patent and basically double your patent length.
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You do know the R&D stands for research and design.
Apart from the fact that it stands for research and development, you are quite correct.
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It means R&D will be spend on NEW medicine. Much less will be spent on slightly improving existing medicine. You do know the R&D stands for research and design. They would have to do some NEW research.
Financially it makes much more sense to take your existing product, make it slightly stronger or last slightly longer and file for a new patent and basically double your patent length.
Yes and no. The patent on the original drug STILL runs out. So, anybody can make the drug that they could have made even if the new drug weren't developed. The only thing that gets patent protection is the tweaked molecule - there is no extension for the original one.
I think the only thing that should matter to patients is whether the new drug is worth it. If it isn't, then don't buy it - just buy the old drug, which would be unpatented and cheap. If it is worth it, then do buy it. If you allow tweake
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They'll still develop them, as they have a major captive market in the US.
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Re:Innovation (Score:5, Insightful)
They seem to understand "My right to live trumps your supposed 'right' to make money" pretty damned well, though.
Re:Innovation (Score:4, Insightful)
They seem to understand "My right to live trumps your supposed 'right' to make money" pretty damned well, though.
That's kill the goose that laid the golden gate logic. The new drug wouldn't have been tested if the company had known it couldn't be patented in advance. They would only have had the option of using the old drug - an option they would still have had if they had ruled differently (the patent for new drug A2 does not extend the patent on related drug A1).
I do agree that the way we fund drug development is highly regressive. I'm all for public R&D going to license-free drugs. However, don't think that it will somehow magically make the drugs cheaper - it will only change who pays for them.
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Well, taxpayers are paying the money, just in the form of drug prices.
Both models have their advantages. I'd like to see some Government drug R&D (end-to-end, royalty-free) if for no reason other than seeing for sure if it works. If you spend a few billion dollars on R&D in a fairly open manner something good is likely to come of it at least in terms of spin-offs, and when you compare that to stuff like bombing Arabs it seems like a decent investment.
If it doesn't work out then we can stop arguing
Re:The morality of the pharmaceutical companies (Score:5, Insightful)
This bullshit has gone on for long enough. Most of the actual research whose fruits end up as drugs are often made by researchers with federal funding. The actual amount of money put into research is much lower than what Pharma wants us to believe, and often R&D involves a significant amount of activities unconnected with Research. Hence, you will be unable to find actual cost of research for any pharma company - inspite of all the financial documents available for the public firms.
High risk and high reward is a again a bit of an overkill considering that most of the research dollars are spent on coming up with new compounds/drugs which are barely more effective than the medicines they replace. These new drugs are significantly more expensive than the drugs they replace and accompanied by huge marketing campaigns that increase pressure on the doctors by the patients clamoring for the new drug.
In addition they keep coming up with small changes to existing compounds and re-patent it .. thus circumventing the very process which they seem to talk so much about. Even when 'evergreening' does not work, they try to involve the generic manufacturer into drawn out legal process. Again - all this inspite of the 1984 Hatch-Waxman act which pushes the patent during out to make up for time spent in research before the actual drug is released.
Considering the Pharma industry has spent over $2.1B in lobbying alone (for stuff like faster approvals, no volume pricing negotiations for Medicare etc.) .. I think it is one of the most corrupt industries in USA>
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The real question is can you run the whole system well enough with government money. While it is true that a lot of the basic research is done with government money, it seems that most of the work that turns the scientific discovery into a working medicine is done by the pharmaceutical industry, and a lot of the costs on the way are there because of the complex regulatory framework -- necessary because of the need for safe medication. It is unclear if enough effort will go into pharmaceuticals unless there
Re:The morality of the pharmaceutical companies (Score:5, Interesting)
India said no to that. They said that Novartis had its run of the full duration of patent protection and that it wouldn't be fooled.
Also Novartis does bill patients thousands of dollars per month for this particular drug. Which is extortionist. A little bit competition is more than just a little bit needed.
The big news is India said no while Europe and the US said yes.
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Without the big investment by the pharmaceutical companies, new drugs would not have existed in the first place.
I don't believe that. More money goes into lobbying for preferential treatment and marketing than development, while many older, perfectly suitable remedies are taken off the market and prohibited altogether. And before anybody goes off about safety issues, they should read up on the deaths and other side effects caused by many of the new drugs. Modern pharma is a pretty corrupt operation. Regulat
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More money goes into lobbying for preferential treatment and marketing than development, while many older, perfectly suitable remedies are taken off the market and prohibited altogether.
If a pharma company publicly argues that an old version of its product is unsafe then aren't they opening themselves up to huge liability claims, and even criminal negligence charges if they sat on that information until after they patent version 1.0.1a?
BS Alert (Score:2)
This is the BS line pharma companies would like to feed you. Much of the research happens in conjunction with universities.
Pharma companies are always in for a "maintenance" cure. They do not want the permanent cure. Corporations exist for profit, and if they get less profit, it will mean a 50,000$ car instead of a 1000000$ supercar.
But just like the MAFIAA they would like you to believe that they are some kind of angels looking over starving millions.
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I hope so too, but think about it from India's perspective. Their pharma industry stands to make (and has made) a lot of profit via ignoring patent law and producing generic drugs. The patent application was for a small modification yes, but (In this case) only because I
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You seem to be stuck at denial. Perhaps some grief counseling?
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I think it's totally immoral to charge anyone 'poor' (where you define that line isn't something I'll debate about right now) any more than the cost of production, while the cost of R&D can be charged to those who can actually afford it.
If all drug research and production was state-owned everyone would pay towards it through their taxes, so that the poor would rightly pay less than the rich, assuming tax was progressive and enforced properly.
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Probably some kind of legal spiel where they can claim the generic drug some other company can make is similar enough to the new patented one that it could be considered a knock off and hence it's illegal to do it?
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In this case, the original patent could not be granted because India's laws did not recognize patents on drugs at the time. Now India has passed laws recognizing patentable drugs, the company wanted a patent, and claimed one for the existing drug, unpatented because of previous laws, slightly changed.
In this case, a patent would have been reasonable. But if allowed, it would be a precedent that would have been used for evergreening other drug patents in the future. So it was quite rightly disallowed.
There a
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